Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Completed · Phase 3

Conditions studied: Hepatitis C Virus Infection

In brief

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Key facts

Study ID

NCT02201901

Run by

Gilead Sciences

People needed

268

Starts

2014-07-01

Expected to finish

2015-11-01

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent
• HCV RNA > 10\^4 IU/mL at screening
• Chronic HCV infection (≥ 6 months)
• Confirmed CPT class B (7-9) at screening

You may not qualify if…

• Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
• Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Screening ECG with clinically significant abnormalities
• Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
• Laboratory results outside of acceptable ranges at screening

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Monroe, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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